A Randomized, Open label, Non-inferiority trial on the efficacy of Lacosamide versus Duloxetine in Patients with Chemotherapy-induced Polyneuropathy - a strategy trial

Phase 4

Recruiting

Conditions: Chemotherapy-induced polyneuropathy
nerve pain
10034606

Registration Number: NL-OMON52883

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 110

Inclusion Criteria

1. Age> 18 years
2. Able to give oral and written informed consent
3. Presence of CIPN grade 1 or higher according to the NCIC-CTC
4. Pain score of 4 or higher
5. Chemotherapy with taxanes, platinums, vincalkinioids or bortezomib in the
past
6. Presence of symptoms of neuropathic pain at least 3 months after the last
chemotherapy

Exclusion Criteria

1. Allergy to the study medication
2. Epilepsy
3. History of illicit drug or alcohol abuse
4. History of psychosis
5. Pregnancy or lactation
6. Use of anti-epileptic or anti-depressant medication (in particular MAO
inhibitors)
7. Use of CYP1a2 inhibitors (e.g. fluvoxamine, fluocinolone, cimetidine)
8. Concomitant neuropathy other than chemotherapy-induced
9. Moderate and severe liver enzyme abnormalities
10. Kidney dysfunction (GFR < 30 mL/min)
11. Severe heart failure (e.g. as a result of infarction or a structural heart
defect)
12. Heart Rhythm Disorders (including 2nd or 3rd degree atrioventricular (AV)
block and sodium channelopathies.
13. Systolic blood pressure above 180mm Hg with current antihypertensive
medications (according to screening measurement)
14. Any condition that by the judgement of the investigator might interfere
with the investigation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective:<br /><br>To explore the analgesic effect of lacosamide compared to duloxetine in<br /><br>patients with painful chemotherapy-induced polyneuropathy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br>1. To assess the side effect profile of lacosamide and duloxetine<br /><br>2. To phenotype patients with painful chemotherapy-induced polyneuropathy using<br /><br>quantitative sensory testing, conditioned pain modulation, offset analgesia and<br /><br>cornea confocal microscopy<br /><br>3. To correlate the CIPN phenotype of patients with the treatment effect of<br /><br>lacosamide and duloxetine.</p><br>